CMC Regulatory Director - Global Strategy & Submissions
$177k - $278.08kJobRx, Inc.
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience with a strong focus on leading major submissions and ensuring regulatory compliance. This position offers a hybrid work model and a competitive salary ranging from $177,000 to $278,080, alongside comprehensive benefits including health insurance, 401(k) plan, and paid time off. #J-18808-Ljbffr JobRx, Inc.
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the CMC Regulatory Director - Global Strategy & Submissions in Boston, MA vacancy
$177k - $278.08k
Takeda in Boston, MA, is looking for a Regulatory CMC Lead with extensive experience in biopharmaceuticals to develop regulatory strategies and manage global submissions. The ideal candidate possesses 10+ years in the field and strong leadership skills. This hybrid position...Suggested$224.9k - $404.6k
Initial Therapeutics, Inc. is seeking a CMC Regulatory Manager based in Norwood, MA. The role involves leading a team of CMC experts to develop and implement regulatory strategies, ensure submission readiness, and manage interactions with health authorities. Ideal candidates...Suggested- JobRx, Inc. is looking for a Director to define and lead global regulatory strategies in Boston, MA. The ideal candidate will manage the Global Regulatory Teams... ...with regulatory requirements, and oversee all FDA submissions. The role demands strong leadership, extensive...Suggested
$238k - $374k
...Executive Director, Global Regulatory Affairs CMC Early Development Join us as Executive Director, Global Regulatory Affairs CMC Early Development... ...innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase...SuggestedTemporary workLocal areaRemote workTakeda Pharmaceuticals International GmbH
Cambridge, MA1 day ago$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide... ...robust, fit‑for‑phase regulatory strategies for small molecule and biologic products... ...CMC regulatory strategy and key submissions/health authority interactions for...SuggestedFull timeTemporary workLocal areaWorldwideJobRx, Inc.
Boston, MA5 days ago- ...Role This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...develops the regulatory CMC strategy and leads the execution of regulatory... ...of global registrational submissions of complex drug product or...Full timeLocal areaWorldwide
- ...Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing &... ...successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must hold a...
$196.7k - $353.4k
...seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will... ...through commercialization Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence and urgency...Permanent employmentWork at officeWork from homeModerna
Cambridge, MA4 days ago$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...innovative and robust regulatory strategies for medical devices and drug‑device... ...regulatory strategy and major submissions for an assigned portfolio of medical...Minimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide- Scholar Rock is seeking a Director or Senior Director of Regulatory Strategy in Cambridge, MA. This role involves developing global regulatory strategies, representing regulatory affairs... ...with the ability to manage regulatory submissions and engagement with authorities like...
$245k - $300k
Merida Biosciences in Cambridge, MA is seeking a Sr. Director, Regulatory Affairs to lead and execute global regulatory strategies. The ideal candidate will oversee health authority interactions, regulatory submissions, and strategic guidance for innovative therapeutics....$177k - $278.08k
...changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and... ...respective functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Independently authors new...Full timeTemporary workLocal areaWorldwide- EPM Scientific is seeking a Director, Global Regulatory Affairs in Boston. This role provides strategic oversight for global regulatory... .... Responsibilities include developing regulatory strategies, overseeing submissions, and influencing decision-making at all levels. #J...
$212k - $333.19k
Takeda is seeking a Senior Director to define and lead global regulatory strategies in Boston, MA. This role requires over 12 years of experience in the pharmaceutical... ...industry, with a strong emphasis on regulatory submissions and compliance. The ideal candidate will have...- Moderna is seeking a seasoned regulatory leader to develop and execute global regulatory strategies for its oncology portfolio. This role involves leading regulatory submissions, negotiations with health authorities, and shaping strategies for novel therapeutics. The ideal...
- JobRx, Inc. is looking for a Director of Global Regulatory Affairs specializing in Neuroscience. This... ...developing innovative global regulatory strategies and leading Global Regulatory Teams.... ...essential, as you will manage FDA submissions and collaborate with global teams to...
- ...Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This... ...developing and executing regulatory strategies to support global product development, particularly... ...the ability to manage regulatory submissions and work with health authorities such...
- Page Mechanical Group, Inc. is looking for an Executive Director of Regulatory Operations and Submission Management. This strategic role oversees the global regulatory processes ensuring high-quality submissions and compliance across the product lifecycle. The ideal candidate...
- Vertex Pharmaceuticals Inc (US) in Boston is seeking a Regulatory Strategy Associate Director to oversee the development of global regulatory strategies for their portfolio. The role involves leading regulatory submissions and mentoring team members on regulatory frameworks...
$211.85k - $317.78k
...Job Title: Senior Director, Global Regulatory Strategy - Early Development & Business Development Location: Boston, MA At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately...Hourly payTemporary workWork at office3 days per weekAstraZeneca
Boston, MA5 days ago- ...Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the...Worldwide
Allergan
Cambridge, MA5 days ago - ...biotechnology company in Boston is seeking a Regulatory Affairs professional to coordinate and prepare document packages for regulatory submissions. The role involves providing regulatory... ...Affairs experience, particularly with CMC requirements for Small Molecule drugs....Work at office
- ...leading oncology biotech company in Boston seeks an Executive Director of Global Regulatory Affairs. This crucial role involves providing strategic... ..., ensuring compliance, and overseeing global regulatory strategies. The ideal candidate will have over 15 years of...
- Join Takeda as the Director of Global Regulatory Labeling Strategy, based in Boston, MA. You will be responsible for developing and implementing labeling content and strategy for multiple products in various stages of drug development. The role requires 10+ years of pharmaceutical...
- Vertex Pharmaceuticals Inc (US) is seeking a Regulatory Strategy Senior Director to lead the development of regulatory strategies for complex projects... ...is based in Boston and involves overseeing regulatory submissions and communications. The successful candidate will have...
- AstraZeneca is seeking a Senior Regulatory Affairs Director in Boston, MA to lead global regulatory strategy for oncology programs. The role involves overseeing a Global Regulatory Strategy Team and ensuring competitive labeling. The ideal candidate has an advanced degree...Work at officeRemote work
$142.5k - $256.5k
The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory... ...developing global regulatory CMC strategies and collaborating with key stakeholders... ...regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify...Permanent employmentWork at officeWork from home- ...commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing... ...regulatory strategy through BLA submission and approval.... ...and execution of US and global regulatory strategy for... ...regulatory risk assessment, CMC, nonclinical and...
- Allergan is seeking a Director of Regulatory Affairs to develop and implement global regulatory strategies to secure product approvals. The role involves leading the Global Regulatory Product Team and requires strong leadership experience within the pharmaceutical sector...
$218.06k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations... ...Are you ready to set the global regulatory vision for pioneering... ...current stage through BLA submission, ensuring an efficient... ...objectives with clinical, CMC, safety and commercial...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CMC Regulatory Director - Global Strategy & Submissions. Be the first to apply!
Related searches
- regulatory affairs director Boston, MA
- senior regulatory manager Boston, MA
- senior director regulatory affairs Boston, MA
- regulatory affairs manager medical devices Boston, MA
- regulatory operations manager Boston, MA
- compliance director Boston, MA
- operations compliance manager Boston, MA
- regulatory affairs manager pharmaceutical Boston, MA
- regulatory manager Boston, MA
- regulatory & compliance manager Boston, MA